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Abstract
Introduction Stent underexpansion is a predictor of in-stent-restenosis and stent thrombosis. Semi-compliant balloons (SCBs) are generally used for lesion preparation. It remains unknown whether routine predilatation using non-compliant balloons (NCBs) improves stent expansion in ordinary coronary lesions.
Methods The PREdilatation by high-pressure NC balloon catheter for better vessel preparation and Optimal lesion preparation with non-compliant balloons for the implantation of bioresorbable vascular scaffolds studies randomised patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs. Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications were compared.
Results We enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively. Predilatation pressure was higher in the NCB group (24±7 atmospheres (atm) vs 14±3 atm, p<0.0001). Postdilatation using NCBs was performed in 41 (76%) lesions vs 46 (82%) lesions pretreated with NCBs versus SCBs (p=0.57). Similar pressures were used for postdilatation with NCB in both groups (23±8 atm vs 23±9 atm, p=0.65). SEI after stent implantation was 0.88±0.13 in the NCB vs 0.85±0.14 in the SCB group (p=0.18). After postdilatation, SEI increased to 0.94±0.13 in the NCB group vs 0.88±0.13 in the SCB group (p=0.02). No relevant complications occurred.
Conclusions In simple coronary lesions, predilatation/postdilatation with NCBs at high pressures appears to result in better scaffold and stent expansion. Using SCBs only for predilatation might lead to inadequate stent expansion and postdilatation with NCBs might only partially correct this. Predilatation and postdilatation using NCBs at high pressure is safe.
Trial registration number ClinicalTrials.gov no. NCT03518645.
- Angioplasty
- Percutaneous coronary intervention
- Stent
- Scaffold
- Lesion preparation
- Optical coherence tomography
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Footnotes
FC and MB are joint first authors.
Twitter @MatthiasBossard
FC and MB contributed equally.
Contributors FC (principal investigator) designed the study, organised funding, monitored the data collection, wrote the statistical analysis plan and drafted and revised the paper. MB contributed to data collection, data analysis and drafted and revised the paper. WZ monitored the data collection, conducted the core lab and statistical analyses and reviewed the manuscript. FM contributed to the data analyses and drafting of the manuscript. MV and MW contributed to the data collection and reviewing of the manuscript. KPM monitored the data collection, conducted the core lab and statistical analyses and reviewed the manuscript. ST contributed to data collection and reviewed the paper. RK (co-principal investigator) designed the study, organised funding, monitored the data collection, drafted and reviewed the paper.
Funding This is an independent investigator-initiated study. Swiss Interventional Systems (SIS) Medical, Frauenfeld (Switzerland) provided research grants for the Pre-NC and OPRENBIS studies (funding for core-lab analyses).
Competing interests FC has received speaker fees and research grants from Abbott Vascular and SIS Medical. RK has received institutional grant support from Abbott, Biotronik, Biosense Webster, Boston Scientific, Medtronic and SIS Medical. None of the other authors had any relevant conflicts of interest.
Patient consent for publication Not required.
Ethics approval The studies were approved by the local ethics committee and complied with the Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.